MedTrace Logo

A Trial to Evaluate the Male Reproductive Safety of Pretomanid in Adult Male Participants With Drug Resistant Pulmonary Tuberculosis

NCT04179500 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2025-01-17

Study results available
· View outcomes & findings →

Summary

Pretomanid is being used in an antimicrobial combination regimen(s) to treat patients with pulmonary tuberculosis (TB). The primary purpose of the Male Reproductive Safety - "BPaMZ/SEM"- clinical study is to evaluate the potential effect of pretomanid on human testicular function whilst being used in a 26 weeks antimicrobial combination regimen consisting of bedaquiline (B) plus pretomanid (Pa) plus moxifloxacin (M) and pyrazinamide (Z) (BPaMZ).

Conditions

  • Tuberculosis, Pulmonary
  • Tuberculosis, Multidrug-Resistant
  • Tuberculosis, MDR
  • Tuberculosis
  • Drug-Resistant Tuberculosis

Interventions

DRUG

Pretomanid

pretomanid 200 mg (once daily) for 26 weeks (with meal)

DRUG

Bedaquiline

bedaquiline 200 mg (once daily) for 8 weeks (with meal), then bedaquiline 100mg (once daily) for 18 weeks (with meal)

DRUG

moxifloxacin

moxifloxacin 400 mg (once daily) for 26 weeks (with meal)

DRUG

pyrazinamide

pyrazinamide 1500 mg (once daily) for 26 weeks (with meal)

Sponsors & Collaborators

  • Global Alliance for TB Drug Development

    lead OTHER

Principal Investigators

  • Antonio Lombardi, MD · Global Alliance for TB Drug Development

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-16
Primary Completion
2023-06-19
Completion
2024-07-17
FDA Drug
Yes

Countries

  • Georgia
  • South Africa

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04179500 on ClinicalTrials.gov